What Is the Gardasil Lawsuit?
The Gardasil lawsuit is a federal multidistrict litigation against Merck over claims that the Gardasil HPV vaccine caused autoimmune and related injuries. The litigation, formally In re: Gardasil Products Liability Litigation, MDL No. 3036, sits before Judge Kenneth D. Bell in the Western District of North Carolina.
Gardasil is a vaccine against human papillomavirus, a family of viruses linked to several cancers. Merck developed the original four-type Gardasil and the nine-type Gardasil 9. Both products are named in the cases.
Individual patients filed the underlying suits. The litigation is not a certified class action.
“Plaintiffs then sued Merck & Co. and its affiliate, Merck Sharp & Dohme LLC, (together, “Merck”), both of which manufacture Gardasil, in the Western District of North Carolina, the forum for multi-district litigation arising from alleged Gardasil-related injuries.”
Source: United States Court of Appeals for the Fourth Circuit, In re: Gardasil Products Liability Litigation, No. 24-1828, Published Opinion (September 4, 2025)
Why Are People Filing Gardasil Lawsuits?
People are filing Gardasil lawsuits because they developed serious health problems after the vaccine and allege Merck did not warn doctors about those risks. The complaints also allege that Merck concealed information from medical providers.
Plaintiffs describe symptoms that began after one or more Gardasil doses, many of them in teenagers and young women. They include racing heart rate, chronic fatigue and loss of normal ovarian function.
Merck denies the allegations. The company says research and evidence continue to support the safety and efficacy of its HPV vaccines. Bloomberg News notes that mainstream medicine has described Gardasil as safe and effective.
A court has not found that Gardasil caused any plaintiff's injury. The rulings in the litigation turned on federal vaccine law and preemption instead.
What Injuries Are Included in the Gardasil Lawsuit?
The Gardasil lawsuit includes four categories of alleged injury, each tied to symptoms plaintiffs say began after vaccination. Complaints plead them together, and an individual plaintiff may allege more than one.
The categories below describe allegations only. No court has found that Gardasil caused any of these conditions.
Postural Orthostatic Tachycardia Syndrome (POTS)
POTS is a condition in which the heart rate rises sharply after standing up, often with dizziness, fatigue and lightheadedness.
Postural orthostatic tachycardia syndrome is one of the most commonly cited injuries in the Gardasil cases. Plaintiffs allege that symptoms such as palpitations and fainting began after vaccination and limited their daily lives.
Trade press coverage of the bellwether process lists POTS among the lead injuries pleaded across the litigation.
Premature Ovarian Insufficiency
Premature ovarian insufficiency, also called premature ovarian failure, is a loss of normal ovarian function before age 40 that can affect periods and fertility.
Plaintiffs allege that Gardasil is linked to premature ovarian insufficiency, also described in complaints as premature ovarian failure. Reproductive health claims drew particular attention because many recipients were adolescents when vaccinated.
Some plaintiff firms also list premature menopause under this category.
Autoimmune Disorders
An autoimmune disorder is a condition in which the immune system mistakenly attacks the body's own healthy tissue.
Complaints and plaintiff firm summaries name several autoimmune conditions, including idiopathic thrombocytopenic purpura and Guillain-Barre syndrome. Plaintiffs allege the vaccine can trigger these immune responses.
Merck disputes any causal link, and the court record contains no finding that Gardasil caused an autoimmune disorder.
Chronic Pain and Fatigue
Chronic pain and fatigue describe symptoms that last for months or longer, such as persistent pain, exhaustion, headaches and trouble concentrating.
Plaintiffs in the Gardasil cases also describe chronic pain, nerve damage, brain fog, headaches and exhaustion. Complaints present these symptoms as lasting well beyond the vaccination period.
Plaintiffs say these conditions often appeared without a single named diagnosis, which is why complaints list them as separate symptoms.
Who Qualifies for the Gardasil Lawsuit?
You may qualify if:
- You received Gardasil or Gardasil 9 and later developed a condition named in the litigation, such as POTS or premature ovarian insufficiency
- You filed a Vaccine Act petition within 36 months of your first symptom, or an attorney confirms that deadline does not bar you
- You kept vaccination and medical records showing the dose dates and the diagnosis
You may not qualify if:
- You filed a Vaccine Act petition more than 36 months after your first symptom, which the Fourth Circuit treats as binding in later tort suits
- Your claim was already resolved through Merck's settlement program
- You have not received a diagnosis from a treating physician
Eligibility depends on your state's statute of limitations and your medical records. Only a qualified attorney reviewing those records can confirm whether any claim remains open.
What Is the Current Status of the Gardasil MDL?
The current status of the Gardasil MDL is that Merck's settlement agreement is final and the docket has shrunk to six pending federal actions. Merck says it satisfied its obligations under the agreement in its filing for the quarter ended September 30, 2026.
The JPML's report dated November 2, 2026 lists 258 total actions filed since 2022. Two proceedings are tracked separately below.
In re: Gardasil Products Liability Litigation, MDL No. 3036
MDL 3036 is the federal Gardasil litigation in the Western District of North Carolina. Judge Robert J. Conrad Jr. received the cases in August 2022, and Judge Kenneth D. Bell took over in February 2024. The JPML's November 2, 2026 report lists 6 pending actions out of 258 filed.
Judge Bell granted Merck summary judgment on implied preemption in sixteen bellwether cases on March 11, 2025. Plaintiffs appealed, and a separate Vaccine Act ruling reached the Supreme Court, which denied review on March 30, 2026. Merck's agreement to resolve most cases is now final.
| Court | U.S. District Court, Western District of North Carolina, Case No. 3:22-md-03036 |
| Presiding judge | Kenneth D. Bell (originally Robert J. Conrad Jr.) |
| Created | August 2022 (JPML transfer order, 619 F. Supp. 3d 1356) |
| Defendants | Merck & Co., Inc. and Merck Sharp & Dohme LLC |
| Pending actions | 6 (JPML report dated November 2, 2026) |
| Total actions filed | 258 |
| Stage | Settlement final; MDL winding down |
Robi v. Merck, No. BC628589
Robi v. Merck is a separate California state-court case that was set for trial in Los Angeles in July 2026, according to Bloomberg News. The June 2026 settlement deal would also resolve this case. Jennifer Robi alleged that Gardasil caused a heart ailment that left her in a wheelchair.
| Court | California Superior Court, Los Angeles County |
| Case number | BC628589 |
| Plaintiff | Jennifer Robi |
| Defendant | Merck |
| Stage | Resolved through settlement, per Bloomberg News (June 2026) |
How Much Is the Gardasil Lawsuit Payout?
The Gardasil lawsuit payout was reported at more than $50 million across more than 200 cases, according to Bloomberg News citing people familiar with the deal. Merck has not published a total or a per-person amount.
Merck says the payment is considerably less than its anticipated defense costs and not material to the company. Merck did not admit liability, and individual awards under the confidential agreement are not public.
Some plaintiff law firm websites advertise per-claim ranges for premature ovarian failure or autoimmune conditions. Those figures are marketing estimates, not terms taken from any settlement document.
Payout size in an individual case would generally depend on diagnosis, severity, documentation and which proceeding resolved the claim. Only a qualified attorney reviewing your records can speak to a specific situation.
Gardasil Lawsuit Updates and Case Status
Here is the current status of the Gardasil lawsuit, updated with new filings, rulings, and case-count reports as they're confirmed. As of November 2026, MDL 3036, In re: Gardasil Products Liability Litigation reached a settlement, described in the timeline below. The timeline below tracks every confirmed development from the first filing forward.
Gardasil Lawsuit Timeline
HHS adds Gardasil and other HPV vaccines to the Vaccine Injury Table
The Secretary of Health and Human Services added human papillomavirus vaccines, including Gardasil, to the Vaccine Injury Table in 2007. That step placed Gardasil claims inside the Vaccine Act compensation program that later shaped the litigation (72 Fed. Reg. 19937).
The JPML centralizes Gardasil product liability cases in North Carolina
The Judicial Panel on Multidistrict Litigation ordered federal Gardasil and Gardasil 9 product liability cases transferred to Judge Robert J. Conrad Jr. in the Western District of North Carolina. The Panel created MDL 3036, formally In re: Gardasil Products Liability Litigation (619 F. Supp. 3d 1356).
The JPML reports 133 pending actions in MDL 3036
The Panel's January 2024 statistics report showed 133 pending actions in MDL 3036, out of 136 filed since centralization. Judge Conrad was still listed as the presiding judge at that point.
The Gardasil MDL moves to Judge Kenneth D. Bell
Merck reports that the Gardasil MDL was reassigned to Judge Kenneth D. Bell in February 2024. The JPML counted 140 pending actions that month, out of 143 filed.
MDL 3036 reaches 143 pending actions under Judge Bell
The JPML's March 2024 report listed Judge Bell as presiding over 143 pending Gardasil actions, with 146 filed in total.
Judge Bell limits the claims that can proceed under the Vaccine Act
In a ruling on two bellwether cases, the court found that many pleaded theories were disguised design defect or failure-to-warn claims. The Vaccine Act preempts those claims (724 F. Supp. 3d 474). Trade press reports that claims about warnings to medical providers continued.
The JPML counts 168 pending Gardasil actions in April 2024
April 2024 brought a jump from 143 to 168 pending actions in MDL 3036. The Panel's monthly report listed 171 filed in total.
Pending Gardasil cases rise to 189 in May 2024
The Panel's May report showed 189 pending actions and 192 total filings. That was the third straight month of growth in MDL 3036.
June 2024 adds only a handful of cases to MDL 3036
Pending actions edged up to 194 in the JPML's June 2024 report, with 197 filed in total. That was a slower month than the two before it.
The court rejects a constitutional challenge to Gardasil's place on the Vaccine Injury Table
Judge Bell ruled that adding Gardasil to the Vaccine Injury Table did not violate the Presentment Clause or the separation of powers. The Fourth Circuit later upheld that conclusion.
MDL 3036 reaches 197 pending actions in July 2024
The JPML listed 197 pending Gardasil actions in its July 2024 report, out of 200 filed since the MDL began.
The Gardasil MDL crosses 200 pending cases
August 2024 was the first month in which MDL 3036 held more than 200 pending actions. The JPML reported 204 pending and 208 filed.
Pending cases dip to 200 in September 2024
The Panel reported 200 pending actions in September 2024, four fewer than a month earlier, while total filings held at 208.
October 2024 brings MDL 3036 back to 204 pending cases
The JPML's October report showed 204 pending Gardasil actions and 212 filed in total, four more filings than in August.
MDL 3036 closes 2024 with 212 pending Gardasil cases
The Panel's December 2024 report counted 212 pending actions and 220 total filings in the Gardasil MDL.
Pending Gardasil actions reach 218 in January 2025
Six more actions joined MDL 3036 between the December and January reports, bringing the pending count to 218 out of 226 filed.
The Gardasil MDL grows to 225 pending actions
The JPML's February 2025 report listed 225 pending actions and 233 total filings in MDL 3036.
MDL 3036 reports 232 pending cases as summary judgment arrives
The Panel counted 232 pending actions and 240 total filings in March 2025, the month Judge Bell ruled on the sixteen bellwether cases.
Judge Bell grants Merck summary judgment on preemption in sixteen bellwether cases
Judge Bell granted Merck summary judgment in sixteen Gardasil bellwether cases on implied preemption grounds. Trade press reports that Merck could not have changed the label under the FDA's Changes Being Effected rule without newly acquired information.
MDL 3036 peaks at 233 pending actions
The JPML's April 2025 report showed the highest pending count in the data collected for this page, 233 actions. Total filings stood at 241.
Plaintiffs file a notice of appeal to the Fourth Circuit
Plaintiffs in MDL 3036 filed their notice of appeal on April 10, 2025, challenging the March 11 summary judgment order on failure-to-warn claims.
Pending actions fall to 219 in May 2025
The Panel's May report listed 219 pending actions but 243 filed in total, a gap of 24 between the two figures.
The Fourth Circuit hears argument in the Vaccine Act timeliness appeals
A Fourth Circuit panel heard argument on May 15, 2025, in appeals brought by three plaintiffs whose Vaccine Act petitions were dismissed as untimely.
MDL 3036 holds steady at 220 pending actions in June and July 2025
The JPML reported 220 pending actions in both its June and July 2025 reports, with total filings at 244.
August 2025 shows 223 pending Gardasil actions
The Panel's August report listed 223 pending actions and 247 filed in total in MDL 3036.
The Fourth Circuit affirms dismissal of three Gardasil bellwether cases
Chief Judge Diaz wrote a published opinion, joined by Judges Niemeyer and Berner, affirming the dismissals as untimely under the Vaccine Act. The court also held that adding Gardasil to the Vaccine Injury Table was constitutional.
The JPML counts 224 pending Gardasil actions in September 2025
September 2025 closed with 224 pending actions and 248 total filings, the last report before the Merck settlement agreement.
Merck signs a proposed agreement to resolve most Gardasil cases
Merck entered into a proposed agreement with plaintiffs' counsel in October 2025 to substantially resolve U.S. Gardasil product liability litigation. The JPML's October report then showed pending actions falling from 224 to 123, with 252 filed in total.
MDL 3036 reports 129 pending actions and 258 filed in November 2025
The Panel's November 2025 report listed 129 pending actions and 258 total filings. Both figures then stayed unchanged in every monthly report through July 2026.
Plaintiffs ask the Supreme Court to review the Fourth Circuit ruling
Plaintiffs filed a certiorari petition, No. 25-924, on February 2, 2026, asking the Supreme Court to review the Fourth Circuit's Vaccine Act decision. Merck waived its right to respond on March 5.
The Supreme Court denies review of the Gardasil Vaccine Act ruling
The Supreme Court denied the petition in Needham v. Merck & Company, No. 25-924, on March 30, 2026, leaving the Fourth Circuit's September 2025 opinion in place.
Bloomberg reports Merck will settle more than 200 Gardasil cases
Bloomberg News reported that Merck would pay more than $50 million to settle more than 200 cases, including Robi v. Merck, set for trial the following month. Merck said it would end the litigation except for one case. Merck did not admit liability.
Merck's quarterly filing says the Gardasil settlement agreement is final
Merck's Form 10-Q for the quarter ended June 30, 2026, states that the settlement conditions were met and the agreement is now final. Merck describes the payment as not material to the company.
The JPML count for MDL 3036 drops from 129 to 7 pending actions
The Panel's August 2026 report listed only 7 pending actions in MDL 3036, out of 258 filed. The settlement had closed most of the docket.
Merck reports that it has satisfied its Gardasil settlement obligations
Merck's Form 10-Q for the quarter ended September 30, 2026, states that the agreement is final. Merck says it has satisfied its obligations under it. The JPML's report dated November 2, 2026, lists 6 pending actions in MDL 3036.
How to File a Gardasil Lawsuit
Here are the 5 steps to file a Gardasil lawsuit.
- Gather your vaccination and medical records: Collect the dates of each Gardasil dose and the diagnosis records from treating physicians.
- Note the date of your first symptom: The Vaccine Act sets a 36-month deadline that runs from the first symptom, so an accurate date matters.
- Check the Vaccine Act program first: Federal law generally requires a petition in the Court of Federal Claims before a tort suit against a vaccine maker.
- Confirm your state deadline: State statutes of limitations differ, and a missed deadline can bar a claim permanently.
- Consult a vaccine injury attorney: Merck's settlement is final, so an attorney can confirm which remedies, if any, remain open.
Gardasil Lawsuit is no longer accepting new claims. Merck's settlement of the bulk of U.S. Gardasil cases is final, and MDL 3036 is down to six pending actions, so the main litigation track is closed to new participants.
What Evidence Do You Need for a Gardasil Lawsuit?
Evidence for a Gardasil lawsuit centers on proof of vaccination, a physician diagnosis and a clear timeline of the first symptom. The timeline matters most, because the Vaccine Act deadline runs from that date.
- Vaccination records: clinic or pharmacy records showing each Gardasil or Gardasil 9 dose date.
- Diagnosis records: notes and test results from treating physicians for the claimed condition.
- Symptom history: a dated account of when symptoms first appeared and how they progressed.
- Vaccine Act filings: any petition and special master decision, which are public court records.
What Did Merck Allegedly Know About Gardasil Risks?
Plaintiffs allege Merck knew or should have known about Gardasil's alleged risks and did not disclose them to medical providers. Merck denies the allegations and says its research supports the vaccine's safety.
The court did not decide what Merck knew. The March 2025 summary judgment turned on preemption, described above, not on a finding about Merck's knowledge.
| Item | Detail |
|---|---|
| Defendants | Merck & Co., Inc. and Merck Sharp & Dohme LLC |
| Products | Gardasil (types 6, 11, 16, 18) and Gardasil 9 (nine types) |
| Regulatory status | On the Vaccine Injury Table since 2007 (72 Fed. Reg. 19937) |
| Reported scale | More than 900 million doses distributed; $8.9 billion in 2023 sales (Bloomberg News) |
| Related figure | Robert F. Kennedy Jr. helped prepare the Robi claims before becoming HHS Secretary (Bloomberg News) |
How Does the Gardasil Lawsuit Compare to Related Cases?
The Gardasil lawsuit differs from the Robi state case and from Vaccine Act petitions, which are separate proceedings with their own rules. A reader comparing outcomes should keep the three apart.
| Proceeding | Where | Nature |
|---|---|---|
| Gardasil MDL 3036 | W.D.N.C. federal court | Individual product liability suits centralized for pretrial work |
| Robi v. Merck, BC628589 | Los Angeles Superior Court | Single-plaintiff state tort case |
| Vaccine Act petitions | Court of Federal Claims special masters | No-fault compensation program with a 36-month filing limit |
The Vaccine Act program is a federal compensation system, not a lawsuit against Merck. The Fourth Circuit held that a timely petition there is a prerequisite to a tort suit.
Frequently Asked Questions
What is the Gardasil lawsuit about?
The Gardasil lawsuit is about claims that Merck's HPV vaccine caused autoimmune and related injuries. Plaintiffs also allege that Merck did not warn of those risks. Plaintiffs filed individual product liability suits, and federal cases were centralized as MDL 3036 in North Carolina. Merck denies that Gardasil causes the alleged injuries.
Is the Gardasil lawsuit a class action or an MDL?
The Gardasil lawsuit is a multidistrict litigation, MDL 3036, not a class action. An MDL groups individual federal cases for shared pretrial work, and each plaintiff keeps a separate claim. Some law firm websites use the phrase class action loosely, but the JPML docket is an MDL.
Did Merck settle the Gardasil lawsuits?
Merck settled the bulk of the U.S. Gardasil lawsuits, and Merck's SEC filings say the agreement is now final. Bloomberg News reported a total above $50 million across more than 200 cases. Merck did not admit liability, and the company calls the payment not material.
How much is the Gardasil lawsuit payout?
The Gardasil lawsuit payout was reported at more than $50 million in total, according to Bloomberg News citing people familiar with the deal. Merck has not published a figure or any per-person amount. Individual payouts under the confidential agreement are not public.
Can you still file a Gardasil lawsuit in 2026?
Filing a Gardasil lawsuit in 2026 is difficult because the main settlement is final and MDL 3036 has only six pending actions. The Fourth Circuit also held that a timely Vaccine Act petition must come before a tort suit. That petition is due within 36 months of the first symptom. A qualified attorney must review each situation.
How is the Gardasil lawsuit different from the Robi v. Merck case?
The Robi v. Merck case is a separate California state-court action, while the Gardasil lawsuit in MDL 3036 sits in federal court in North Carolina. Robi was set for a Los Angeles trial before the settlement. The two proceedings had separate dockets and separate case counts.